BORTEZOMIB- bortexomib injection, powder, lyophilized, for solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Bortezomib (UNII: 69G8BD63PP) (Bortezomib - UNII:69G8BD63PP)

Verfügbar ab:

Dr.Reddy's Laboratories, Inc.

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma. Bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma. Bortezomib for injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions [seeAdverse Reactions (6.1)] . Bortezomib for injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib for injection. Risk Summary Based on its mechanism of action [see Clinical Pharmacology ( 12.1)] and findings in animals, bortezomib can cause fetal harm when administered to a pregnant woman. There are no studies with the use of bortezomib in pregnant women to inform drug-associated risks. Bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose (see Data) . Advise pregnant women of the potential risk to the fetus.

Produktbesonderheiten:

Bortezomib for Injection is supplied as individually cartoned 10 mL vials containing 3.5 mg of bortezomib as a white to off-white cake or powder. NDC 43598-426-60 3.5 mg single-dose vial Unopened vials may be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light. Follow guidelines for handling and disposal for hazardous drugs, including the use of gloves and other protective clothing to prevent skin contact1 .

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

BORTEZOMIB- BORTEXOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
DR.REDDY'S LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BORTEZOMIB FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BORTEZOMIB FOR
INJECTION.
BORTEZOMIB FOR INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Bortezomib for injection is a proteasome inhibitor indicated for:
treatment of adult patients with multiple myeloma (1.1)
treatment of adult patients with mantle cell lymphoma (1.2)
DOSAGE AND ADMINISTRATION
For subcutaneous or intravenous use only. Each route of administration
has a different reconstituted
concentration. Exercise caution when calculating the volume to be
administered. (2.1, 2.10)
The recommended starting dose of bortezomib for injection is 1.3 mg/m
administered either as a 3 to
5 second bolus intravenous injection or subcutaneous injection. (2.2,
2.4, 2.6)
Retreatment for Multiple Myeloma: May retreat starting at the last
tolerated dose. (2.6)
Hepatic Impairment: Use a lower starting dose for patients with
moderate or severe hepatic
impairment. (2.8)
Dose must be individualized to prevent overdose. (2.10)
DOSAGE FORMS AND STRENGTHS
For injection: Single-dose vial contains 3.5 mg of bortezomib as
lyophilized white to off-white cake or
powder for reconstitution and withdrawal of the appropriate individual
patient dose. (3)
CONTRAINDICATIONS
Patients with hypersensitivity (not including local reactions) to
bortezomib, boron, or mannitol, including
anaphylactic reactions. (4)
Contraindicated for intrathecal administration. (4)
WARNINGS AND PRECAUTIONS
Peripheral Neuropathy: Manage with dose modification or
discontinuation. (2.7) Patients with pre-
existing severe neuropathy should be treated with bortezomib for
injection only after careful risk-benefit
assessment. (2.7, 5.1)
Hypotension: Use caution when treating patients taking
antihypertensives, with a history of synco